DIANEAL PD1 GLUCOSE 1.36% W/V (13.6MG/ML) SOLUTION
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
18-04-2024
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Active ingredient:
GLUCOSE SODIUM CHLORIDE SODIUM LACTATE CALCIUM CHLORIDE DIHYDRATE MAGNESIUM CHLORIDE HEXAHYDRATE
Available from:
Baxter Healthcare Limited
Dosage:
1.36 %w/v
Pharmaceutical form:
Solution for Dialysis
Authorization date:
1979-12-18
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dianeal PD1 Glucose 1.36% w/v 13.6 mg/ml Solution for Peritoneal Dialysis.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One litre of Peritoneal Dialysis Solution contains:
This provides:
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for peritoneal dialysis.
A clear, colourless, sterile aqueous solution, packed in PVC containers, each contained is a sealed plastic overpouch.
The container may be fitted with an integral drainage/administration set.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Dianeal PD1 is indicated whenever peritoneal dialysis is employed, including:
1.
Acute and chronic renal failure.
2.
Severe water retention.
3.
Electrolyte Disorders.
4.
Drug intoxication, when a more adequate therapeutic alternative is not available.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_Administration_
DIANEAL PD1 is intended for intraperitoneal administration only. Not for intravenous administration.
Peritoneal dialysis solutions may be warmed to 37°C to enhance patient comfort. However, only dry heat (for example,
heating pad, warming plate) should be used. Solutions should not be heated in water due to an increased risk of
contamination. Solutions should not be heated in a microwave oven due to the potential for damage to the container
and patient injury or discomfort.
Anhydrous Glucose
13.60
g
which may be present as Glucose Monohydrate
15.00
g
Sodium Chloride
5.67
g
Sodium lactate
3.92
g
Calcium Chloride Dihydrate
257.00
mg
Magnesium Chloride Hexahydrate
152.00
mg
Sodium
132.00
mmol
Calcium
1.75
mmol
Magnesium
0.75
mmol
Chloride
102.00
mmol
Lactate
35.00
mmol
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 08/02/2012_
_CRN 2
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